| Methods |
Study design: RCT
Study grouping: parallel group
Unit of randomisation: individuals
Power (power sample size calculation, level of power achieved): not specified for total study
Imputation of missing data: not specified; probably available‐case analysis (only participants who completed TSST |
| Participants |
Country: USA
Setting: laboratory
Age: mean = 19.53 years (analysed sample)
Sample size (randomised): not specified; probably 107
Sex: 105 women
Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: no exact values for state anxiety specified
Population description: undergraduate women
Method of recruitment: not specified
Inclusion criteria: 1) reported no use of oral contraception or other prescription medication; 2) fluent in English; 3) non‐smokers; 4) non‐drug users; 5) physically healthy (no reported fever or illnesses, no diseases or conditions that may impact stress responses such as endocrine disorders, autoimmune disorders, cardiovascular or respiratory conditions, etc.)
Exclusion criteria: 1) drinking caffeinated or alcoholic beverages in the 3 hours prior to the TSST; 2) exercising in the 3 hours prior to the TSST; 3) consuming anything other than water for the hour prior; 4) using any drugs or medications for 24 hours prior
Attrition (withdrawals and exclusions): 3 exclusions from salivary biomarker analyses; 1 withdrew; 1 was withdrawn
Reasons for missing data: 2 withdrawals: 1 refused to do TSST, i in high distress at baseline (i.e. pale, shaking, appearing physical unwell); 3 exclusions from salivary biomarker analyses due to technical problems |
| Interventions |
Intervention: self‐compassion training (n randomised not specified)
delivery: instructions by voice recordings in a laboratory room; recordings at home accessed through secure website providers: experimenters (female experimenters and 2 TSST judges: 1 male, 1 female) duration of treatment period and timing: 2 sessions scheduled 4 days apart (session 1: 10‐minute recording, listening to similar recording once a day for the following 3 days; session 2: final 5‐minute recording and TSST between 1 pm and 6 pm); 45 minutes in total -
description:
Meditations focused on cultivating kindness and acceptance towards the self, and to a lesser extent towards others Meditations consisted of phrases (“may I be happy...may I be at ease...”; p 4) that women were asked to repeat silently with intention and self‐kindness Phrases included traditional and study‐specific content that drew from Neff's (Neff 2003a; Neff 2003b) conceptualisation of self‐compassion (“may I know that my joys and struggles are shared by others...”; p 4). 1 female voice was used for instructions in both active conditions -
SESSION 1:
10‐minute, condition‐specific recording opportunity to ask questions participants instructed to listen to a “similar recording" (p 4) once a day for the following 3 days (‘self‐compassion’ or ‘meditation’ not mentioned) participants instructed that attending to recordings is "extremely important" and "may help prepare for second session" and should be listened to at home "without any distractions" (p 4)
-
SESSION 2 (TSST session):
Prior to TSST instructions, women in self‐compassion condition listened to final 5‐minute condition‐specific recording with instructions that: “The rest of the study will be challenging. To help you prepare for the challenge, we invite you to listen to a recording similar to the ones you listened to at home...”. (p 4)
compliance: no difference between self‐compassion and attention control in frequency of audio‐recordings use between session 1 (s1) (mean = 3.00; SD = 0.57) and and session 2 (s2) (mean = 2.80; SD = 0.69): t(76.11) = −1.44, P = 0.15, d = 0.33). No differences on a 5‐item, study‐specific measure (α = 0.80) concerning attention to the recordings (e.g. "I tried my best to stay focused on the recordings"; p 6), using a 0 ‐ 4 scale, with higher scores = greater attention); both groups indicated relatively high compliance (self‐compassion: mean = 3.29 (SD = 0.67); attention control: mean = 3.06 (SD = 0.64); t(83) = −1.59, P = 0.12, d = 0.35) integrity of delivery: Independent evaluators blind to condition viewed randomly‐selected live sessions in the second half to check for consistency in experimenter behaviour; no results specified economic information : course credit or payment for study participation theoretical basis: based on self‐compassion literature (Neff 2003a; Neff 2003b); work builds on nascent work in this area (Fredrickson 2008; Kok 2013; Pace 2009) in important ways
Control 1: attention control (placebo; n randomised not specified)
delivery: instructions by voice recordings in a laboratory room; recordings at home accessed by secure website providers: experimenters (female experimenters and 2 TSST judges: 1 male, 1 female) duration of treatment period and timing: 2 sessions scheduled 4 days apart (session 1: 10‐minute recording, listening to similar recording once a day for 3 following days; session 2: final 5‐minute recording and TSST between 1 pm and 6 pm); 45 minutes in total -
description :
control recordings: excerpts from a psychology textbook chapter on cognition, with content plausibly relevant to TSST preparation, including discussions of problem‐solving, judgement, and thinking 1 female voice used for instructions in both active conditions -
SESSION 1:
10‐minute, condition‐specific recording opportunity to ask questions participants instructed to listen to a “similar recording" (p 4) once a day for the following 3 days (‘self‐compassion’ or ‘meditation’ were not mentioned); participants instructed that attending to recordings is "extremely important" and "may help prepare for second session" and should be listened to at home "without any distractions" (p 4)
-
SESSION 2 (TSST session):
Prior to TSST instructions, women in attention‐control condition listened to final 5‐minute condition‐specific recording with instructions that: “The rest of the study will be challenging. To help you prepare for the challenge, we invite you to listen to a recording similar to the ones you listened to at home...” (p4)
compliance: no difference between self‐compassion and attention control in frequency of audio‐recordings use between s1 (mean = 3.00; SD = 0.57) and and s2 (mean = 2.80; SD = 0.69): t(76.11) = −1.44, P = 0.15, d = 0.33. No differences on a 5‐item, study‐specific measure (α = 0.80) concerning attention to the recordings (e.g. "I tried my best to stay focused on the recordings"; p 6), using a 0‐to‐4 scale, with higher scores = greater attention); both groups indicated relatively high compliance (self‐compassion: mean = 3.29 (SD = 0.67); attention control: mean = 3.06 (SD = 0.64); t(83) = −1.59, P = 0.12, d = 0.35) integrity of delivery: Independent evaluators blind to condition viewed randomly‐selected live sessions in the second half to check for consistency in experimenter behaviour; no results specified economic information (intervention cost, changes in other costs as result of intervention): course credit or payment for study participation theoretical basis: not specified
Control 2: no intervention (n randomised not specified)
providers: experimenters (female experimenters and 2 TSST judges: 1 male, 1 female) duration of treatment period and timing: 2 sessions scheduled 4 days apart (no listening to recordings in or between sessions, but TSST in second session between 1 pm and 6 pm) description: participants did not listen to recordings during or between sessions; invited to sit quietly or read (provided) neutral‐content magazines during the s2 period that women in the other conditions heard the recording integrity of delivery: independent evaluators blind to condition viewed randomly‐selected live sessions in the second half to check for consistency in experimenter behaviour; no results specified economic information: course credit or payment for study participation
|
| Outcomes |
Outcomes collected and reported:
self‐compassion (trait and state) ‐ Self Compassion Scale state anxiety ‐ Subjective Units of Distress state anxiety ‐ State‐Trait Anxiety Inventory salivary cortisol ‐ saliva samples salivary alpha‐amylase ‐ saliva samples high‐frequency heart rate variability (respiratory sinus arrhythmia) ‐ ECG
Time points measured and reported:
TRAIT & STATE SELF‐COMPASSION: 1) pre‐intervention (beginning of s1); 2) during intervention (beginning of s2); 3) post‐intervention and after stressor exposure in TSST (35 minutes post TSST) SALIVARY BIOMAKERS (5 assessments during s2): 1) during intervention, before stressor exposure in TSST/baseline TSST; 2) post‐intervention, immediately after stressor exposure in TSST; 3) post‐intervention, 10 minutes after TSST; 4) post‐intervention, 20 minutes after TSST; 5) post‐intervention, 35 minutes after TSST SUDS (6 assessments during s2): 1) during intervention, before stressor exposure in TSST/baseline TSST; 2) during intervention, in speech preparation phase of TSST; 3) post‐intervention, immediately after stressor exposure in TSST; 4) post‐intervention, 10 minutes after TSST; 5) post‐intervention, 20 minutes after TSST; 6) post‐intervention, 35 minutes after TSST STAI (4 assessments during s2): 1) during intervention, before stressor exposure in TSST/baseline TSST; 2) during intervention, in speech preparation phase of TSST; 3) post‐intervention, 10 minutes after TSST; 4) post‐intervention, 20 minutes after TSST RSA: 1) during intervention, before stressor exposure in TSST/baseline TSST (5 minutes); 2) during intervention, 5 minutes in speech preparation phase of TSST; 3) during intervention and during TSST (10 minutes); 4) post‐intervention, after TSST (10 minutes in recovery phase)
Adverse events: not specified |
| Notes |
Contact with authors: We contacted the study authors for the number of participants randomised in total (N = 107?) and to each group, as well as the means and SDs for all outcomes at each measurement point with the number of participants analysed, respectively. In another inquiry, we asked whether healthcare students were included in the sample. We received the response that the "majors of the undergraduate female subjects in the study had not been asked; however, they were recruited from an Intro Psychology class and the corresponding author was sure that a decent portion went on to be psychology majors, although she had no way of knowing which ones" (quote; Arch 2019 [pers comm]).
Study start/end date: not specified
Funding source: 1 author supported with startup funds from the University of Colorado Boulder; 1 author partially supported by National Institutes of Health (NIH) grant (CA126971)
Declaration of interest: All study authors declare that they have no conflicts of interest
Ethical approval needed/obtained for study: human participants IRB approval
Comments by study authors: not relevant
Miscellaneous outcomes by the review authors: according to the study authors, undergraduates were recruited from introductory psychology classes; but it is unclear if the final sample included participants who were psychology major students
Correspondence: Joanna J Arch, PhD; Department of Psychology and Neuroscience, University of Colorado Boulder, 345 UCB Muenzinger, Boulder, CO, 80309‐0345 USA; Joanna.Arch@Colorado.edu; telephone: 303‐492‐4634 |
